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Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial (THIAMINE-HF)

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ClinicalTrials.gov Identifier: NCT03228030
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
McMaster/St. Peter's Hospital Chair of Aging
Information provided by (Responsible Party):
McMaster University ( Hamilton Health Sciences Corporation )

Brief Summary:
Heart failure (HF) is a major cardiovascular disease with increasing prevalence. Thiamine deficiency is common in HF patients. Previous small studies have shown that thiamine supplementation can improve left ventricular systolic function in HF, but larger clinical studies are lacking. Given the ease of supplementation and the potential benefits in HF, we aim to conduct a pilot randomized controlled trial (RCT) using high dose thiamine supplementation in HF patients. The main goal of this pilot study is to determine the feasibility of recruitment for an RCT of thiamine supplementation.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure With Reduced Ejection Fraction Thiamine Deficiency Congestive Heart Failure Dietary Supplement: Thiamine Dietary Supplement: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thiamine Supplementation in Heart Failure: a Pilot Randomized Controlled Crossover Trial
Actual Study Start Date : April 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Thiamine mononitrate 500mg po daily
3 months on thiamine, followed by 6 week washout period, and then 3 months on placebo arm
Dietary Supplement: Thiamine
Capsules

Placebo Comparator: Placebo
3 months on placebo, followed by 6 week washout period, and then 3 months on thiamine
Dietary Supplement: Placebo
Identical capsules




Primary Outcome Measures :
  1. Recruitment [ Time Frame: 11 months ]
    Number of participants recruited during the study period. This is a feasibility outcome.


Secondary Outcome Measures :
  1. Refusal rate [ Time Frame: 11 months ]
    Number of eligible individuals refusing to participate in the research study. This is a feasibility outcome

  2. Retention rate [ Time Frame: 11 months ]
    Number of participants completing the study.

  3. Compliance rate [ Time Frame: 11 months ]
    Proportion of participants with >80% adherence to intervention.

  4. Left ventricular ejection fraction (LVEF) [ Time Frame: 3 months ]
    Echocardiogram measurement of left ventricular ejection fraction.

  5. Peak global longitudinal strain (%) [ Time Frame: 3 months ]
    Speckle tracking echocardiogram measurement of heart contractility. This is a more sensitive measurement of heart function than LVEF.

  6. NT-proBNP [ Time Frame: 3 months ]
    Heart failure biomarker

  7. New York Heart Association (NYHA) class [ Time Frame: 3 months ]
    Heart function symptom grading

  8. Quality of life [ Time Frame: 3 months ]
    Kansas City Cardiomyopathy Questionnaire

  9. HF hospitalizations [ Time Frame: 7.5 months ]
    Number of hospital stays >24h

  10. HF emergency room visits [ Time Frame: 7.5 months ]
    Number of hospital visits <24h

  11. Death due to cardiovascular causes [ Time Frame: 7.5 months ]
    As adjudicated by study committee



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥60
  • NYHA class II-IV symptoms
  • Recent HF-related admission in past 12 months OR NT-proBNP >600ng/L within 60 days of screening
  • LVEF ≤45% on 2D/3D echocardiography or radionuclide angiography (RNA) in the past 12 months (on optimal therapy)
  • Medically optimized prior to enrolment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker (± neprilysin inhibitor), β-blocker, and/or aldosterone antagonist at target or maximally tolerated doses.
  • Patients must be stable on medications without hospitalization in the past month.

Exclusion Criteria:

  • Taking >2.5mg/d of thiamine supplement. Allows standard multivitamin. B complex vitamin not allowed due to high thiamine content.
  • Unable to swallow study medication. A placebo swallowing test will take place at screening.
  • Clinical indication for thiamine supplementation including symptomatic thiamine deficiency (Wernicke's encephalopathy, severe malnutrition, refeeding syndrome) and heavy alcohol use, >15 standard drinks per week in men and >10 standard drinks per week in women.
  • End-stage renal disease on dialysis
  • Severe mitral valve disease because this impacts the accuracy of speckle tracking analysis on echocardiography.
  • Non-English speaking (unable to complete questionnaires).
  • Unable to provide written consent.
  • Cognitive impairment without a caregiver administering medications.
  • Expected survival <1 year due to non-cardiac disease.
  • Expected heart transplantation in <6 months (± left ventricular assistive device).
  • Allergies to the ingredients of the study medication or placebo

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228030


Contacts
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Contact: Catherine Demers, MD MSc FRCPC 905-521-2100 ext 73324 demers@hhsc.ca

Locations
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Canada, Ontario
McMaster University Recruiting
Hamilton, Ontario, Canada, L8N3Z5
Contact: Catherine Demers, MD, MSc, FRCPC    905-521-2100 ext 73324    demers@hhsc.ca   
Sponsors and Collaborators
Hamilton Health Sciences Corporation
McMaster/St. Peter's Hospital Chair of Aging
Investigators
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Principal Investigator: Eric KC Wong, MD FRCPC McMaster University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hamilton Health Sciences Corporation
ClinicalTrials.gov Identifier: NCT03228030     History of Changes
Other Study ID Numbers: 15-387
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by McMaster University ( Hamilton Health Sciences Corporation ):
thiamine
heart failure
heart failure with reduced ejection fraction
geriatric
thiamin
vitamin b1
congestive heart failure

Additional relevant MeSH terms:
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Heart Failure
Thiamine Deficiency
Beriberi
Heart Diseases
Cardiovascular Diseases
Vitamin B Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Thiamine
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs